Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Other: Constant gait speed group; Other: Increasing gait speed group

• Registration Number: NCT03991364
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

Brief Summary

Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Last Update Submitted: 2019-06-18
• Study First Posted: 2019-06-19
• Last Update Posted: 2019-06-19
• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Hemiplegic patients secondary to first cerebrovascular accidents
• Functional ambulation category score ≥ 3

Exclusion Criteria

• History of surgery of affected lower limb
• Fracture of affected lower limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Constant gait speed group	Constant gait speed group	experimental group that applied the speed of the robot-assisted gait training constantly
Increasing gait speed group	Increasing gait speed group	control group that applied the gradual increase of the speed of the robot-assisted gait training

Primary Outcome Measures

Name	Time	Method
Energy expenditure (EE)	2 weeks after baseline	EE(kcal/min): energy expenditure per minute

Secondary Outcome Measures

Name	Time	Method
deoxygenated hemoglobin (DeoxyHb)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	deoxygenated hemoglobin concentration of cortical activation
Lower extremity Fugl-Meyer Assessment	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
Heart rate (HR)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	Cardiac frequency
Respiratory Quotient (R)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	Respiratory quotient
Energy expenditure (EE)	baseline, 1 weeks after baseline, 3 weeks after baseline	EE(kcal/min): energy expenditure per minute
oxygenated hemoglobin (OxyHb)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	oxygenated hemoglobin concentration of cortical activation
Volume of Oxygen (VO2)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	O2 consumption/1min
Metabolic equivalent (METS)	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min
10m walk test	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
Functional Ambulation Category	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
timed up and go test	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline	simple test used to assess a person's mobility and requires both static and dynamic balance

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of